(254 days)
No
The document describes a mechanical implant (femoral stem) and its intended use, materials, and testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for use in hip replacement due to various medical conditions, including osteoarthritis and rheumatoid arthritis, and to restore mobility, all of which are therapeutic interventions.
No
The device described is a hip implant (femoral stem) used for replacement surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical femoral stem made of Ti-6Al-4V, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral stem, a component of a hip implant, made of titanium and intended for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.
Product codes
MEH
Device Description
The Novation Element Press-Fit Femoral Stem is manufactured from Ti-6Al-4V with a grit blast surface and HA coating. The stem has a 12/14 taper. The Novation Element Press-Fit Femoral stem is available in a standard and high neck offset configurations, and collared and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Novation Element Press-Fit Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: HA coating characterization, distal fatigue testing, and range of motion analysis were performed to demonstrate that the proposed Exactech Novation Element Press-Fit Femoral Stems are substantially equivalent to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2016
Exactech® Incorporated Thomas McNamara Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K153649
Trade/Device Name: Exactech® Novation® Element Press-fit Femoral Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH Dated: July 29, 2016 Received: August 1, 2016
Dear Thomas McNamara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153649
Device Name
Exactech® Novation® Element Press-Fit Femoral Stem
Indications for Use (Describe)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
· Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date: | August 30, 2016 | |
| Contact Person: | Thomas McNamara
Regulatory Affairs Specialist | |
| | Phone: (352) 377-1140
Fax: (352) 378-2617 | |
| Proprietary Name: | Exactech® Novation® Element Press-Fit Femoral Stem | |
| Common Name: | Femoral Stem | |
| Classification Name: | Hip Joint Metal/Ceramic/Polymer Semi-Constrained
Cemented Or Nonporous Uncemented Prosthesis, 21 CFR
888.3353, Class II, Product Code MEH | |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- Exactech Novation Element Press-Fit Femoral Stem (K080980)
Device Description
The Novation Element Press-Fit Femoral Stem is manufactured from Ti-6Al-4V with a grit blast surface and HA coating. The stem has a 12/14 taper. The Novation Element Press-Fit Femoral stem is available in a standard and high neck offset configurations, and collared and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Novation Element Press-Fit Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Novation Element press-fit femoral stems with HA coating are intended for press-● fit fixation.
4
Exactech® Novation® Element Press-Fit Femoral Stem Traditional 510(k) - 510(k) Summary
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- . Indications for Use. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices have the same indications for use.
- . Materials/Surface Finish/Coatings. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices are composed of the same biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
- Design Features. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices share the same design features.
- . Dimensions. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices are dimensionally comparable.
- . Sterilization. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices are provided sterile for single use only.
- . Performance Requirements. The proposed Exactech Novation Element Press-Fit Femoral Stems and the predicate devices conform to recognized performance standards for total shoulder replacement devices.
Non-Clinical Testing
The only modification to the proposed Exactech Novation Element Press-Fit Femoral Stems is the vendor applying the HA coating. No other changes were made to the proposed device. HA coating characterization, distal fatigue testing, and range of motion analysis were performed to demonstrate that the proposed Exactech Novation Element Press-Fit Femoral Stems are substantially equivalent to the identified predicate devices.
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech Novation Element Press-Fit Femoral Stems demonstrates substantial equivalence to the referenced predicate devices.